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PN-PROS: Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale

Sponsor
Boston Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05373979
Collaborator
National Jewish Health (Other), Geisinger Clinic (Other), The Hospital for Sick Children (Other), Stanford University (Other)
340
Enrollment
1
Location
48.9
Anticipated Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test a pediatric narcolepsy patient reported outcomes tool to assess pediatric narcolepsy symptoms and their effect on daily functioning and quality of life. The goal is to develop a clinical survey that can improve the care of pediatric narcolepsy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    WHO IS ELIGIBLE?

    • Children and adolescents with narcolepsy between the ages of 9-17 years

    • Diagnosis must be verified by a signed letter from physician in order to participate

    • Participants must be able to understand the purpose of the study

    PARTICIPATION DETAILS

    • Upon enrollment participants will receive an email containing a link to complete HIPAA compliant online surveys about narcolepsy symptoms, quality of life, and daily function. Surveys should take no more than 30 minutes.

    • One week later, some participants will receive another email with a link to complete a 10-minute follow up survey

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    340 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale (PN-PROS)
    Actual Study Start Date :
    Apr 2, 2019
    Anticipated Primary Completion Date :
    Apr 30, 2023
    Anticipated Study Completion Date :
    Apr 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Narcolepsy

    Narcolepsy type 1 (NT1 or narcolepsy with cataplexy) and Narcolepsy type 2 (NT2 or narcolepsy without cataplexy)
    Obstructive Sleep Apnea

    mild to moderate obstructive sleep apnea (OSA; obstructive AHI of 1-15/hour)

    Outcome Measures

    Primary Outcome Measures

    1. Survey Validation [2 Years]

      To evaluate the content validity and reliability of the PN-PROs item pools through a field test of the item pools in a diverse, national sample of pediatric narcolepsy patients with a comparator group of pediatric mild obstructive sleep apnea patients (9-17 years).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children and adolescents ages 9-17

    • Have a diagnosis of narcolepsy type 1, narcolepsy type 2, or mild to moderate obstructive sleep apnea (OSA)

    Exclusion Criteria:

    • A history of visual or hearing impairment

    • A co-morbid neurodevelopmental disorder such as autism or schizophrenia

    • No access to computer/tablet/smart phone to complete questionnaires

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Children's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Boston Children's Hospital
    • National Jewish Health
    • Geisinger Clinic
    • The Hospital for Sick Children
    • Stanford University

    Investigators

    • Principal Investigator: Kiran Maski, MD, MPH, Boston Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kiran Maski, Principal Investigator, Boston Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT05373979
    Other Study ID Numbers:
    • IRB-A00029346
    First Posted:
    May 13, 2022
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sleep Apnea, Obstructive
    Narcolepsy

    Study Results

    No Results Posted as of Jun 1, 2022